ACTD |ASEAN Common Technical Dossier |Dossier Preparation

What is ASEAN

ACTD is valid for ASEAN countries. The Association of Southeast Asian Nations (ASEAN) was established on 8 August 1967. The Member States are Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar,
Philippines, Singapore, Thailand and Viet Nam.

Scope of The Guideline

This document is intended to provide guidance on the format of a registration application for drug products regarding ASEAN CTR. This format is appropriate for NCE (New Chemical Entity), Biotech (Biotechnological Products), MaV (Major Variations), MiV (Minor Variations) and G (Generics).
To determine the applicability of this format for a particular type of product, applicant should consult with the appropriate National Regulatory Authorities. The “Body of Data” in this guideline merely indicates where the information should be located. Neither the type nor extent of specific supporting data has been addressed in this guideline and both may depend upon national guidance and or accepted leading international references (pharmacopoeias).

This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common
format for the preparation of a well-structured Common Technical Dossier (CTD) application
that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals and biologics for human use.

Although the current ASEAN Common Technical Requirements (ACTR) has not included specific requirements for biosimilar products, the ACTD format is also applicable for biosimilar products. This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements.

This guideline merely demonstrates an appropriate write-up format for acquired data.
However, applicants can modify, if needed, to provide the best possible presentation of the technical information in order to facilitate the understanding and evaluation of the results upon pharmaceutical registration.

The ASEAN Common Technical Dossier (ACTD) is a standardized format for submitting regulatory applications for pharmaceutical products in the Association of Southeast Asian Nations (ASEAN) region. The ACTD is similar to the Common Technical Document (CTD), which is used by regulatory agencies in other parts of the world, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

The ACTD is divided as follows:

1. Administrative information: This section includes information on the marketing authorization holder (MAH), the product’s brand name and generic name, and the intended use of the product. It also includes the product’s summary of product characteristics (SmPC) and patient information leaflet (PIL), which provide important information for healthcare professionals and patients on the use, dosage, and potential side effects of the product.
2. Quality: This section provides information on the quality and manufacturing of the product, including the pharmaceutical form, composition, and methods of manufacture. It also includes data on the stability of the product and a description of the manufacturing site.
3. Nonclinical study reports: This section includes nonclinical studies that have been conducted to evaluate the safety and effectiveness of the product. These may include studies on the product’s pharmacology, toxicology, and environmental impact.
4. Clinical study reports: This section includes clinical studies that have been conducted to evaluate the efficacy and safety of the product in humans. These may include data on the study design, population, results, and any adverse events that occurred during the study.

The Common Technical Document is organized into four parts as follows:

Part I. Table of Contents, Administrative Data and Product Information

Part I contains initially the overall Table of Contents of the whole ACTD to provide basically the information that could be looked through respectively. Secondly, the next content is the Administrative Data where required specific documentation in detail is put together such as application forms, label, package insert etc. The last section of this part is Product Information where necessary information includes prescribed information, mode of action, side effects etc.
A general introduction to the pharmaceutical, including its pharmacologic class and mode of action should be included.

Subparts of part I

Section A: Introduction
Section B: Overall ASEAN Common Technical Dossier Table of Contents
Section C: Documents required for registration (for example, application forms, labelling, Product Data Sheet, prescribing information)

Part II. Quality Document

Part II should provide the Quality Overall Summary followed by the Body of Data. The quality control document should be described in detail as much as possible.

Subparts of Quality Document

Section A: Table of Contents
Section B: Quality Overall Summary
Section C: Body of Data

Part III. Nonclinical Document

Part III should provide the Nonclinical Overview, followed by the Nonclinical Written Summaries and the Nonclinical Tabulated Summaries. The documentation of this part is not required for Generic Products, Minor Variation Products and some Major Variation Products.
For ASEAN member countries, the Study Reports of this part may not be required for NCE, Biological Products and other Major Variation Products if the Original Products are already registered and approved for market authorization in Reference Countries. Therefore, the authority who requires specific Study Reports should ask for the necessary documents.

Subparts of Nonclinical Document

Part III: Nonclinical Document
Section A: Table of Contents
Section B: Nonclinical Overview
Section C: Nonclinical Written and Tabulated Summaries

1. Table of Contents
2. Pharmacology
3. Pharmacokinetics
4. Toxicology

Section D: Nonclinical Study Reports

1. Table of Contents
2. Pharmacology
3. Pharmacokinetics
4. Toxicology

Part IV. Clinical Document

Part IV should provide the Clinical Overview and the Clinical Summary. The documentation of this part is not required for Generic Products, Minor Variation Products and some Major Variation Products. For ASEAN member countries, the Study Reports of this part may not be required for NCE, Biological Products and other Major Variation Products if the Original Products are already registered and approved for market authorization in Reference Countries. Therefore, the authority who requires specific Study Reports should ask for the necessary documents.

Subparts of the clinical document

Section A: Table of Contents
Section B: Clinical Overview
Section C: Clinical Summary

1. Summary of Biopharmaceutics and Associated
   Analytical Methods
2. Summary of Clinical Pharmacology Studies
3. Summary of Clinical Efficacy
4. Summary of Clinical Safety
5. Synopses of Individual Studies
   Section D: Tabular Listing of All Clinical Studies
   Section E: Clinical Study Reports
   Section F: List of Key Literature References

For the ACTD format used in Malaysia click here

Original Guidance can be found in below file

For more articles on regulatory guidance follow below link

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